Cerebral PalsyNCT07325981
Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adherence, and Engagement in Children With Cerebral Palsy: A RCT
A study testing exergaming, biofeedback-enhanced exergaming and Traditional Physical Therapy in people with Cerebral Palsy, run by Ziauddin University at 1 site in Pakistan.
Trial summary
Cerebral Palsy (CP) accounts for approximately 0.9% of the global disease burden and affects 2.4-4% of children under 5 years old, with associated developmental and coordination impairments. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- exergaming, biofeedback-enhanced exergaming and Traditional Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Dec 2025to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with Cerebral Palsy (CP), specifically spastic diplegia, spastic hemiplegia, or mild ataxia.
- Gross Motor Function Classification System (GMFCS) Level I or II.
- Male and female aged between 6 and 12 years at the time of enrollment.
- Manual Ability Classification System (MACS) Level I or II.
- Able to follow simple two-step commands, with or without augmentative and alternative communication (AAC).
- Demonstrates adequate cognitive functioning based on the NIH Toolbox Picture Sequence Memory Test (PSMT), scoring at or above the 25th percentile (T-score ≥ 40) based on age-adjusted norms.
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- Hearing and vision adequate to participate in exergaming tasks (with or without assistive devices).
- Able to stand and participate in basic movements with or without minimal assistance.
- Willingness to participate and written informed consent from parent/guardian with assent from the child.
Who cannot join
- GMFCS Level III or higher, indicating significant gross motor limitations.
- MACS Level III or higher, indicating significant manual impairment.
- Severe uncorrected visual or hearing impairment that would interfere with interaction during exergaming.
- Uncontrolled epilepsy or other neurological condition contraindicating active movement.
- Significant behavioral or attention challenges that prevent engagement with game-based tasks.
- Score below the 25th percentile on the PSMT, indicating insufficient episodic memory to follow game tasks.
- Involvement in any other intervention trial that may interfere with study participation.
- Medical conditions that contraindicate participation in physical activity (as determined by a physician).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Ziauddin University
Karachi, Sindh, 75850
Associate Professor/ Post Graduate Director FAHS, PhD, +92 324 2497814, amnakhan@zu.edu.pk
About this study
Official title: Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adherence, and Engagement in Children With Cerebral Palsy (GMFCS I-II): A Randomized Controlled Trial
Cerebral Palsy (CP) accounts for approximately 0.9% of the global disease burden and affects 2.4-4% of children under 5 years old, with associated developmental and coordination impairments. Pediatric physical therapy aims to enhance independence and quality of life; however, maintaining adherence to conventional treatment remains a major challenge due to its repetitive and monotonous nature, leading to reduced motivation and limited functional progress.
Exergaming, integrating physical activity with interactive video games, has emerged as an engaging alternative shown to improve motor function, balance, and coordination in children with motor impairments. While existing evidence supports its effectiveness, few randomized studies have explored the addition of real-time physiological biofeedback (e.g., surface EMG with motion tracking) within exergaming platforms. Evidence on adherence and engagement outcomes also remains limited.
This trial addresses that gap by investigating the combined effects of biofeedback-enhanced exergaming versus exergaming alone and traditional physiotherapy in children with CP (GMFCS levels I-II). Incorporating real-time biofeedback provides immediate physiological feedback, potentially enhancing motor learning, motivation, and adherence, key components for improving long-term rehabilitation outcomes in pediatric populations.
Read the detailed description
This single-blinded randomized controlled trial will be conducted at Ziauddin Hospital and the IHRI Rehabilitation Centre and School, Karachi, Pakistan. A total of 90 children (aged 6-12 years) with spastic diplegic or hemiplegic cerebral palsy (GMFCS levels I-II) will be recruited through purposive sampling and stratified by age band (6-8 vs. 9-12 years) and GMFCS level. Participants will be randomized (1:1:1) into three intervention groups using computer-generated permuted blocks with allocation concealment via sealed envelopes.
Outcome assessors and data analysts will be blinded. Inclusion requires adequate cognition (NIH Toolbox PSMT ≥ 25th percentile), functional mobility, and hearing/vision sufficient for exergaming tasks. Exclusion criteria include severe motor, cognitive, or sensory impairments, uncontrolled epilepsy, behavioral challenges, or concurrent clinical trial participation. The sample size (n=90) was determined via G*Power (effect size f=0.30, α=0.05, power=0.80) to detect clinically meaningful between-group differences in motor function (BOT-2).
- Conditions
- Cerebral Palsy
- Being tested
- exergaming, biofeedback-enhanced exergaming, Traditional Physical Therapy
- Keywords
- cerebral palsy, exergaming, bio-feedback, GMFCS, traditional physical therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exergamingOther
The exergaming program will use Kinect Adventures (River Rush, Reflex Ridge) for balance and agility, Kinect Sports for lower-limb activation and coordination, Just Dance Kids for rhythmic stepping, and Kinect Party/Happy Action Theater for free movement. Optional MIRA Rehab modules may target posture and agility. Sessions will occur three times weekly for twelve weeks, beginning with a light warm-up, followed by 20-30 minutes of targeted exergames, and ending with a cool-down. Game difficulty will increase as children improve, and therapists will track progress using scores and completion times.
biofeedback-enhanced exergamingOther
This group will perform the same exergames as Intervention 1 but with real-time visual, auditory, and optional vibration feedback to enhance motor learning. Surface EMG (Delsys Trigno) will record bilateral muscle activity, and Microsoft Kinect SDK (v2/Azure) will track joint motion and posture. Session frequency and duration will be identical.
Traditional Physical TherapyOther
Children in this group will receive standard physical therapy to improve gross motor function, especially balance and mobility. Sessions will be held three times per week for twelve weeks, lasting 30-45 minutes. The protocol includes a 5-minute warm-up, 12-15 minutes of strengthening for hip, knee, and ankle muscles, 8-10 minutes of balance training using wobble boards or foam, and 8-10 minutes of functional mobility tasks such as sit-to-stand and stair practice, followed by a 2-5 minute cool-down. Therapists will follow standardized instructions, and treatment fidelity will be monitored through checklists, with 10% of sessions audited monthly.
| Study group | Role | What they receive |
|---|---|---|
| exergaming | Experimental | The exergaming program will use Kinect Adventures (River Rush, Reflex Ridge) to train balance, agility, and trunk control; Kinect Sports to improve lower-limb activation, hand-eye coordination, and bilateral movements; Just Dance Kids for rhythmic stepping; and Kinect Party/Happy Action Theater to encourage free movement. Optional MIRA Rehab modules may target posture and agility. Sessions will be held three times per week for twelve weeks, starting with a light warm-up, followed by 20-30 minutes of targeted exergames, and ending with a cool-down. Game difficulty will progressively increase, and therapists will track progress through scores and completion times. Receives: Other: exergaming |
| biofeedback-enhanced exergaming | Experimental | This group will perform the same exergaming activities as the exergaming group, with the added integration of real-time multimodal biofeedback to enhance motor learning. The frequency and duration of sessions will be identical to the exergaming group. Participants will receive on-screen visual guides that indicate whether their movements are being performed correctly, along with auditory feedback through performance-linked cues such as pitch changes or sound alerts prompting postural adjustments. Optional vibration alerts from wearable devices may also be used to correct improper posture. The biofeedback system will incorporate surface EMG (Delsys Trigno) to assess bilateral muscle activity during gameplay, and motion tracking through the Microsoft Kinect SDK (v2 or Azure) to capture and analyze joint movements, posture, and detailed ranges of motion. Receives: Other: biofeedback-enhanced exergaming |
| traditional physical therapy | Active comparator | Children in this group will receive standard physical therapy to improve gross motor function, especially balance and mobility. Sessions will be held three times per week for twelve weeks, lasting 30-45 minutes. The protocol includes a 5-minute warm-up, 12-15 minutes of strengthening for hip, knee, and ankle muscles, 8-10 minutes of balance training using wobble boards or foam, and 8-10 minutes of functional mobility tasks such as sit-to-stand and stair practice, followed by a 2-5 minute cool-down. Therapists will follow standardized instructions, and treatment fidelity will be monitored through checklists, with 10% of sessions audited monthly. Receives: Other: Traditional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Improvement
Outcome Measure Title:
Gross Motor Function Measure (GMFM-88) total score (%)
Description:
Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88), a standardized observational tool evaluating motor skills across five domains: lying \& rolling, sitting, crawling \& kneeling, standing, and walking/running/jumping. Scores are expressed as a percentage of the maximum possible score.
Score range: 0-100% Interpretation: Higher scores indicate better gross motor function.
Measured: 4-6 months
Balance Performance
Outcome Measure Title:
Pediatric Balance Scale (PBS) total score
Description:
Balance performance will be measured using the Pediatric Balance Scale (PBS), a functional balance assessment adapted from the Berg Balance Scale. The scale consists of 14 tasks assessing static and dynamic balance during functional activities.
Score range: 0-56 Interpretation: Higher scores indicate better balance performance.
Measured: 4-6 months
Postural Control
Outcome Measure Title:
Postural stability parameters derived from Kinect-based motion analysis
Description:
Postural control stability will be quantified using Kinect-based motion tracking, capturing center of mass displacement, joint angles, and sway during task-based activities. Movement stability indices (e.g., reduced sway amplitude and improved alignment) will be derived from kinematic data.
Measurement units: Degrees (joint angles), millimeters (displacement), task-specific stability indices Interpretation: Lower sway and improved alignment indicate better postural stability.
Measured: 4-6 months
Functional Mobility
Outcome Measure Title:
Timed Up and Go (TUG) test duration (seconds)
Description:
Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time required to stand from a seated position, walk 3 meters, turn, return, and sit down.
Score range: Continuous variable (seconds) Interpretation: Shorter completion times indicate better functional mobility.
Measured: 4-6 months
Secondary outcomes (3)
Muscle Activation Patterns
Outcome Measure Title:
Surface electromyography (sEMG) amplitude and activation timing during task performance
Description:
Surface EMG will be used to record muscle activation amplitude and timing during functional tasks. Outcome variables will include normalized EMG amplitude and coordination patterns across target muscle groups.
Measurement units: Microvolts (µV), normalized activation ratios Interpretation: More efficient and coordinated activation patterns indicate improved motor control.
Measured: 4-6 months
Game performance score
Score range: System-generated scores Interpretation: Higher game scores indicate improved motor learning and performance.
Measured: 4-6 months
task completion time during virtual-based tasks
Description:
Motor learning including task completion time generated by the virtual rehabilitation system.
Interpretation: reduced completion times indicate improved motor learning and performance.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start15 Dec 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this experimental study design, participants will be randomly assigned to one of three separate intervention groups: exergaming, biofeedback-enhanced exergaming, and traditional physical therapy. Each group will receive only one intervention throughout the entire study period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziauddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sajid Iqbal, Ziauddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325981
- Sponsor's protocol ID
- 11120925SIPT
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant confidentiality and institutional policy restrict the sharing of individual-level data.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biofeedback-Enhanced Exergaming, Exergaming Alone, and Traditional Physical Therapy on Motor Function, Adherence, and Engagement in Children With Cerebral Palsy (GMFCS I-II): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07325981
- Acronym / sponsor ID
- 11120925SIPT
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, exergaming, bio-feedback, GMFCS, traditional physical therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ziauddin UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cerebral Palsy (CP) accounts for approximately 0.9% of the global disease burden and affects 2.4-4% of children under 5 years old, with associated developmental and coordination impairments. Pediatric physical therapy aims to enhance independence and quality of life; however, maintaining adherence to conventional treatment remains a major challenge due to its repetitive and monotonous nature, leading to reduced motivation and limited functional progress.
Exergaming, integrating physical activity with interactive video games, has emerged as an engaging alternative shown to improve motor function, balance, and coordination in children with motor impairments. While existing evidence supports its effectiveness, few randomized studies have explored the addition of real-time physiological biofeedback (e.g., surface EMG with motion tracking) within exergaming platforms. Evidence on adherence and engagement outcomes also remains limited.
This trial addresses that gap by investigating the combined effects of biofeedback-enhanced exergaming versus exergaming alone and traditional physiotherapy in children with CP (GMFCS levels I-II). Incorporating real-time biofeedback provides immediate physiological feedback, potentially enhancing motor learning, motivation, and adherence, key components for improving long-term rehabilitation outcomes in pediatric populations.
Detailed description
This single-blinded randomized controlled trial will be conducted at Ziauddin Hospital and the IHRI Rehabilitation Centre and School, Karachi, Pakistan. A total of 90 children (aged 6-12 years) with spastic diplegic or hemiplegic cerebral palsy (GMFCS levels I-II) will be recruited through purposive sampling and stratified by age band (6-8 vs. 9-12 years) and GMFCS level. Participants will be randomized (1:1:1) into three intervention groups using computer-generated permuted blocks with allocation concealment via sealed envelopes.
Outcome assessors and data analysts will be blinded. Inclusion requires adequate cognition (NIH Toolbox PSMT ≥ 25th percentile), functional mobility, and hearing/vision sufficient for exergaming tasks. Exclusion criteria include severe motor, cognitive, or sensory impairments, uncontrolled epilepsy, behavioral challenges, or concurrent clinical trial participation. The sample size (n=90) was determined via G*Power (effect size f=0.30, α=0.05, power=0.80) to detect clinically meaningful between-group differences in motor function (BOT-2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- In this experimental study design, participants will be randomly assigned to one of three separate intervention groups: exergaming, biofeedback-enhanced exergaming, and traditional physical therapy. Each group will receive only one intervention throughout the entire study period.
| Arm | Type | Receives |
|---|---|---|
| exergaming | Experimental | Other: exergamingThe exergaming program will use Kinect Adventures (River Rush, Reflex Ridge) to train balance, agility, and trunk control; Kinect Sports to improve lower-limb activation, hand-eye coordination, and bilateral movements; Just Dance Kids for rhythmic stepping; and Kinect Party/Happy Action Theater to encourage free movement. Optional MIRA Rehab modules may target posture and agility. Sessions will be held three times per week for twelve weeks, starting with a light warm-up, followed by 20-30 minutes of targeted exergames, and ending with a cool-down. Game difficulty will progressively increase, and therapists will track progress through scores and completion times. |
| biofeedback-enhanced exergaming | Experimental | Other: biofeedback-enhanced exergamingThis group will perform the same exergaming activities as the exergaming group, with the added integration of real-time multimodal biofeedback to enhance motor learning. The frequency and duration of sessions will be identical to the exergaming group. Participants will receive on-screen visual guides that indicate whether their movements are being performed correctly, along with auditory feedback through performance-linked cues such as pitch changes or sound alerts prompting postural adjustments. Optional vibration alerts from wearable devices may also be used to correct improper posture. The biofeedback system will incorporate surface EMG (Delsys Trigno) to assess bilateral muscle activity during gameplay, and motion tracking through the Microsoft Kinect SDK (v2 or Azure) to capture and analyze joint movements, posture, and detailed ranges of motion. |
| traditional physical therapy | Active comparator | Other: Traditional Physical TherapyChildren in this group will receive standard physical therapy to improve gross motor function, especially balance and mobility. Sessions will be held three times per week for twelve weeks, lasting 30-45 minutes. The protocol includes a 5-minute warm-up, 12-15 minutes of strengthening for hip, knee, and ankle muscles, 8-10 minutes of balance training using wobble boards or foam, and 8-10 minutes of functional mobility tasks such as sit-to-stand and stair practice, followed by a 2-5 minute cool-down. Therapists will follow standardized instructions, and treatment fidelity will be monitored through checklists, with 10% of sessions audited monthly. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Diagnosed with Cerebral Palsy (CP), specifically spastic diplegia, spastic hemiplegia, or mild ataxia.
- Gross Motor Function Classification System (GMFCS) Level I or II.
- Male and female aged between 6 and 12 years at the time of enrollment.
- Manual Ability Classification System (MACS) Level I or II.
- Able to follow simple two-step commands, with or without augmentative and alternative communication (AAC).
Key exclusion criteria (8 listed)
- GMFCS Level III or higher, indicating significant gross motor limitations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exergamingThe exergaming program will use Kinect Adventures (River Rush, Reflex Ridge) for balance and agility, Kinect Sports for lower-limb activation and coordination, Just Dance Kids for rhythmic stepping, and Kinect Party/Happy Action Theater for free movement. Optional MIRA Rehab modules may target posture and agility. Sessions will occur three times weekly for twelve weeks, beginning with a light warm-up, followed by 20-30 minutes of targeted exergames, and ending with a cool-down. Game difficulty will increase as children improve, and therapists will track progress using scores and completion times. | Other | exergaming |
| biofeedback-enhanced exergamingThis group will perform the same exergames as Intervention 1 but with real-time visual, auditory, and optional vibration feedback to enhance motor learning. Surface EMG (Delsys Trigno) will record bilateral muscle activity, and Microsoft Kinect SDK (v2/Azure) will track joint motion and posture. Session frequency and duration will be identical. | Other | biofeedback-enhanced exergaming |
| Traditional Physical TherapyChildren in this group will receive standard physical therapy to improve gross motor function, especially balance and mobility. Sessions will be held three times per week for twelve weeks, lasting 30-45 minutes. The protocol includes a 5-minute warm-up, 12-15 minutes of strengthening for hip, knee, and ankle muscles, 8-10 minutes of balance training using wobble boards or foam, and 8-10 minutes of functional mobility tasks such as sit-to-stand and stair practice, followed by a 2-5 minute cool-down. Therapists will follow standardized instructions, and treatment fidelity will be monitored through checklists, with 10% of sessions audited monthly. | Other | traditional physical therapy |
Primary outcome
Gross Motor Function Improvement
Time frame: 4-6 months
Outcome Measure Title: Gross Motor Function Measure (GMFM-88) total score (%) Description: Gross motor function will be assessed using the Gross Motor Function Measure-88 (GMFM-88), a standardized observational tool evaluating motor skills across five domains: lying \& rolling, sitting, crawling \& kneeling, standing, and walking/running/jumping. Scores are expressed as a percentage of the maximum possible score. Score range: 0-100% Interpretation: Higher scores indicate better gross motor function.
Balance Performance
Time frame: 4-6 months
Outcome Measure Title: Pediatric Balance Scale (PBS) total score Description: Balance performance will be measured using the Pediatric Balance Scale (PBS), a functional balance assessment adapted from the Berg Balance Scale. The scale consists of 14 tasks assessing static and dynamic balance during functional activities. Score range: 0-56 Interpretation: Higher scores indicate better balance performance.
Postural Control
Time frame: 4-6 months
Outcome Measure Title: Postural stability parameters derived from Kinect-based motion analysis Description: Postural control stability will be quantified using Kinect-based motion tracking, capturing center of mass displacement, joint angles, and sway during task-based activities. Movement stability indices (e.g., reduced sway amplitude and improved alignment) will be derived from kinematic data. Measurement units: Degrees (joint angles), millimeters (displacement), task-specific stability indices Interpretation: Lower sway and improved alignment indicate better postural stability.
Functional Mobility
Time frame: 4-6 months
Outcome Measure Title: Timed Up and Go (TUG) test duration (seconds) Description: Functional mobility will be assessed using the Timed Up and Go (TUG) test, which measures the time required to stand from a seated position, walk 3 meters, turn, return, and sit down. Score range: Continuous variable (seconds) Interpretation: Shorter completion times indicate better functional mobility.
3 secondary outcomes
Muscle Activation Patterns
Time frame: 4-6 months
Game performance score
Time frame: 4-6 months
task completion time during virtual-based tasks
Time frame: 4-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No. Participant confidentiality and institutional policy restrict the sharing of individual-level data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exergaming, biofeedback-enhanced exergaming and Traditional Physical Therapy in people with Cerebral Palsy, run by Ziauddin University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sajid Iqbal Khan, P.hD* (+923322380904, sajidiqbalpn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Improvement (time frame: 4-6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.